Baxter recalls REVACLEAR 300 and 400 dialyzers with potential ruptured fibers that could cause blood leaks during hemodialysis. Affected units have specific lot numbers and product codes.
There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment.
Baxter is recalling REVACLEAR 300 and 400 dialyzers due to a risk of blood leaks from ruptured fibers during treatment. This could cause serious complications for patients undergoing hemodialysis.
Ruptured dialyzer fibers during treatment could lead to blood leaks, potentially causing serious complications like infection or organ damage. This risk occurs when the dialyzer is used in hemodialysis procedures for kidney failure treatment.
Patients using hemodialysis treatment with the recalled dialyzers are most at risk. Healthcare providers who use these devices for chronic or acute renal failure treatment may also be affected.
Check for product code 114745L on REVACLEAR 300 dialyzers. Affected units have specific lot numbers listed in the recall notice, including C419105401 through C419111701.
Look for product code 114745L and lot numbers C419105401 through C419111701 on the dialyzer.
The recall is due to a potential presence of ruptured dialyzer fibers that could lead to blood leaks during hemodialysis treatment.
Check if your dialyzer has product code 114745L and lot numbers from C419105401 to C419111701. If it does, contact Baxter for further instructions.
Yes, ruptured fibers could cause blood leaks during treatment, potentially leading to serious complications like infection or organ damage.
We’ve drafted a message you can send Baxter to request your refund or repair — edit it as you like.
Subject: Recall Z-1908-2019 — Baxter Baxter Hello, I own a Baxter that is covered by recall Z-1908-2019 from Baxter. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
